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NCT Number: NCT04722939

Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury

Introduction. Initiation of acute kidney replacement therapy (KRT) is common in critically ill adults admitted to the intensive care unit (ICU), and is associated with increased morbidity and mortality. KRT has been linked to poor neurocognitive outcomes, leading to a reduced quality of life, as well as increased utilization of healthcare resources. Adults initiated on dialysis in the ICU may be particularly at risk of neurocognitive impairment, as survivors of critical illness are already predisposed to developing cerebrovascular disease and cognitive dysfunction over the long-term relative to healthy controls. Regional cerebral oxygen saturation (rSO2) may provide a critical early marker of long-term neurocognitive impairment in patients in this population. The INCOGNITO-AKI study aims to understand cerebral oxygenation in patients undergoing KRT, either continuous or intermittent, in the ICU. These findings will be correlated with long-term cognitive and functional outcomes, as well as structural brain pathology.

Methods and analysis. 108 patients scheduled to undergo treatment for acute kidney injury with KRT in the Kingston Health Sciences Centre ICU will be recruited into this prospective observational study. Enrolled patients will be assessed with intradialytic cerebral oximetry using near infrared spectroscopy (NIRS). Delirium will be assessed daily with the Confusion Assessment Method-Intensive Care Unit (CAM-ICU) and delirium severity quantified as cumulative CAM-ICU-7 scores. Neurocognitive impairment will be assessed at 3- and 12-months after hospital discharge using the Kinarm and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Structural brain pathology on MRI will also be measured at the same timepoints. Driving safety, adverse events, and medication adherence will be assessed at 12-months to evaluate the impact of neurocognitive impairment on functional outcomes.

Ethics and dissemination. This study has been approved by the Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (Approval number: DMED-2424-20). Results will be presented at critical care scientific conferences and a lay summary will be provided to patients and families in their preferred format.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age greater than or equal to 18 years
  • admitted to the Kingston Health Sciences Intensive Care Unit
  • diagnosis of severe AKI requiring Kidney Replacement Therapy (KRT) (defined by the presence of either a twofold increase in serum creatinine from baseline, serum creatinine level greater than or equal to 354 micromol/L with an increase of 27 micromol/L from baseline, or urine output <6 mL/kg in the preceding 12 hours)
  • within 12 hours of initiation of KRT via intermittent hemodialysis (iHD) or continuous kidney replacement therapy (CKRT).

Exclusion criteria

  • acquired or congenital neurological disorders
  • any contraindication to testing with cerebral oximetry, Kinarm, or MRI (e.g., claustrophobia, limb amputation, paresis, neuromuscular disorders, etc.)
  • KRT via PD
  • failure to consent
  • life expectancy less than 24 hours
  • clinical suspicion of renal obstruction
  • rapidly progressive glomerulonephritis or interstitial nephritis
  • prehospitalization eGFR <30 mL/min/1.73m2.

Treatment and study plan

Cerebral oxygenation

Diagnostic Test

Cerebral oxygenation will be monitored with the FORESIGHT Elite cerebral oximeter during the first 72h of critical illness, and during subsequent hemodialysis sessions

Primary outcomes

  1. Delirium Severity

    Time frame: Patients will be screened daily in the ICU with the CAM-ICU-7 score up until the date of ICU discharge or day 30 of ICU stay.

    Delirium severity will be calculated from the cumulated Confusion Assessment Method-Intensive Care Unit-7 (CAM-ICU-7) score

Secondary outcomes

  1. Cognitive Impairment-Kinarm

    Time frame: 3 months and 12 months

    Patients will undergo a neurocognitive battery with the Kinarm robot and Kinarm standardized tests.

  2. Cognitive Impairment-Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: 3 months and 12 months

    Patients will undergo assessment with the RBANS administered by a trained researcher.

  3. Medication adherence

    Time frame: 12 months

    Medication adherence will be assessed with the Medication Adherence Rating Scale (MARS)

  4. Driving safety-1

    Time frame: 12 months

    Driving safety will be assessed by number of motor vehicle accidents.

  5. Driving safety-2

    Time frame: 12 months

    Driving safety will be assessed by and the Manchester Driver Behavior Questionnaire

  6. Health care utilization

    Time frame: Within 12 months of hospital discharge.

    We will measure emergency department visits and hospital readmissions.

  7. Structural brain imaging

    Time frame: 3 months and 12 months

    Anonymized and de-identified MRI scans will be processed using MIPAV55 v.7.3.0 and Oxford Centre for Functional MRI of the Brain (FMRIB) Software Library (FSL) v.5.0 medical image processing programs. Scans will be corrected for intensity non-uniformity and transformed into a common image space to adjust for variations in head size and orientation. Skull stripping will be performed. Automated and semi-automated techniques will be used to determine whole-brain volumes from T1-weighted images for analysis of macrostructural brain integrity, as well as FA and MD measures from diffusion-weighted images for analysis of microstructural brain integrity. Brain volumes will be corrected for total intracranial volume to account for head size. Reasons for non-completion of MRI scanning will be recorded. Patients will be used as their own controls over time using a within-subjects design.

Study contacts

Contact information is provided by the study sponsor or research team.

J. Gordon Boyd, MD, PhD

CONTACT

[email protected]

613-549-6666 ext. 6228

Tasha Jawa, MSc

CONTACT

[email protected]

416-627-1508

Sponsors and collaborators

Lead sponsor

Dr. Gordon Boyd

Other

Registry information

Official study title

Identifying Neurocognitive Outcomes and Cerebral Oxygenation in Critically Ill Adults on Acute Kidney Replacement Therapy in the Intensive Care Unit

Acronym: INCOGNITOAKI

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Jan 25, 2021
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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